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Inicio Revista Española de Medicina Nuclear e Imagen Molecular (English Edition) Analysis of non-conformity in continuous quality improvement in a Hospital Radio...
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Vol. 36. Issue 2.
Pages 99-102 (March - April 2017)
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Vol. 36. Issue 2.
Pages 99-102 (March - April 2017)
Original Article
Analysis of non-conformity in continuous quality improvement in a Hospital Radiopharmacy Unit
Análisis de las no conformidades en la mejora continua de la calidad en una unidad de radiofarmacia hospitalaria
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T. Martineza,
Corresponding author
, J.F. Contrerasb
a Unidad de Radiofarmacia, Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain
b Servicio de Medicina Nuclear, Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain
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Figures (2)
Tables (3)
Table 1. NC registered in 2012–2015.
Table 2. Data from total NC and those corresponding to prepared and unadministered doses.
Table 3. Total of unadministered and administered doses, PET and SPECT, and ratio in percentage.
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Abstract
Aim

To perform an analysis of non-conformities (NC) registered between 2012 and 2015, as a part of the review process of the Quality Management System of our Radiopharmacy Unit.

Material and methods

Non-conformities registered in the Radiopharmacy Unit in the period 2012–2015 are analyzed and sorted by their impact on the process (critical, major, and minor), cause/origin of the non-conformity, and nature of radiopharmaceutical (PET vs. SPECT).

Results

A decrease in the NC of 20% per year is observed, especially in PET radiopharmaceuticals. Non-conformities in SPECT make up about 62–84% of the total of the NC, mainly related to the high number of doses prepared and not administered, which is about 1.5–3% in the ratio of non-administered/administered per year.

Conclusions

Analysis of the NC can be considered as a useful indicator in assessment of quality assurance, and in our particular case, the decrease in the registration of NC indicates effectiveness in the corrective and preventive actions implemented.

Keywords:
Non-conformity
Quality assurance
Radiopharmacy
Quality Management System
Corrective and preventive actions
Resumen
Objetivo

Analizar las no conformidades (NC) registradas entre el 2012 y el 2015, como parte del proceso de revisión del sistema de gestión de calidad.

Material y métodos

Se analizan las NC registradas en la unidad de radiofarmacia en el período indicado, incluyendo clasificación según repercusión en el proceso, origen de la incidencia y naturaleza del radiofármaco.

Resultados

Se observa un descenso de las NC en torno al 20% cada año, provocado fundamentalmente por la disminución de las NC en PET. Las NC en convencional se deben en gran medida al número de dosis preparadas y no administradas (62-84% del total de NC), que en el cómputo global de dosis totales administradas representan un porcentaje del 1,5 al 3% en el ratio de las no administradas/administradas por año.

Conclusiones

El análisis de las NC se puede considerar como un indicador útil en la evaluación de la calidad asistencial. En nuestro caso, su disminución nos indica que las medidas correctoras y preventivas implantadas hasta ahora han sido efectivas.

Palabras clave:
No conformidad
Sistema de gestión de calidad
Radiofarmacia
Sistema de gestión de calidad
Acciones correctivas y preventivas

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